蟾酥凝胶贴膏成型工艺的研究

目的:以蟾酥制备外用止痛的蟾酥凝胶贴膏,通过对蟾酥凝胶贴膏的空白基质进行优选,从而确定最佳的空白基质配比;对蟾酥凝胶贴膏中蟾酥的加入量进行考察,确定其最佳的载药量。方法:通过预试验确定蟾酥凝胶贴膏的基质组成,该凝胶贴膏的基质配方组成采用正交试验法进行优选,将剥离强度作为蟾酥凝胶贴膏的主要考察指标,将膏体的涂展性作为辅助的观察指标。在保证凝胶贴膏成型性良好的前提下,以每贴基质中蟾酥的最大含量作为该凝胶贴膏的载药量。结果:混合保湿剂组成为甘油-丙二醇(13∶1),基质配方确定为混合保湿剂、水、聚丙烯酸钠、羧甲基纤维素钠、明胶、卡波姆,其比例为4.0∶3.0∶0.4∶0.1∶0.2∶0.25,在pH值为8时制备的蟾酥凝胶贴膏各种指标均较好。蟾酥凝胶贴膏载药量定为每贴50 mg。结论:确定的蟾酥凝胶贴膏基质配方和载药量制成的凝胶贴膏成型性和黏附性较好,载药量大,工艺合理可行,能适合生产的需要。

Study on the Forming Process of Bufonis Venenum Gel Plaster

Objective:Bufonis Venenum gel plaster for pain relieving was prepared. The blank matrix of Bufonis Venenum gel plaster was tested so as to determine the optimized composition ratio of the blank matrix. Also the loading amount of Bufonis Venenum was tested to determine the optimized amount.Method:Through preliminary test the composition of matrix was determined. The matrix formulation of the gel plaster was optimized by the orthogonal test,and the peel strength was used as a main indicator of the gel plaster,and the spreadability of the plaster was used as an auxiliary observation index. Under the premise of ensuring good moldability of the gel plaster,the maximum amount of Bufonis Venenum in each matrix was used as the loading amount of Bufonis Venenum for the gel plaster. Results:The composition of the mixed moisturizer was glycerol-propylene glycol(13∶1),and the ratio of the matrix composition was determined to be a mixed moisturizer,water,sodium polyacrylate,sodium carboxymethylcellulose,gelatin,and carbomer,with the ratio of 4.0 ∶3.0 ∶0.4 ∶0.1∶0.2∶0.25. The indexes of gel plaster paste prepared at pH 8 were the best. The loading amount of Bufonis Venenum was set at 50 mg per sticker. Conclusion:The Bufonis Venenum gel plaster prepared with the optimized composition and the drug-loading amount is of better moldability and adhesion,large drug loading,reasonable and feasible process,and it is suitable for production.